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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01899-34 | Other Identifier | IDRCB |
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Abbott has discontinued marketing of the medical device under investigation. FREESTYLE LIBRE 2 has been replaced by FREESTYLE LIBRE 2+, whose characteristics have been slightly modified.
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Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes.
The benefit of therapeutic education (TPE) has been clearly established on glycaemic control.
Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications.
The investigators therefore propose a prospective randomised study in 2 arms :
Main objective to the investigators is to determine the benefit of continuous interstitial glucose monitoring (by fresstyle 2) for 28 days coupled with standard TPE (Patient Therapeutic Education) vs standard TPE alone in newly diagnosed type 2 diabetics on HbA1c at 3 months.
The secondary objectives are to evaluate the effect of the TPE coupled with FSL vs TPE alone on :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People living with diabete standard TPE | Active Comparator | HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months |
|
| People living with diabete standard TPE + FSL 28 days | Experimental | Continuous mesure of glucose (FSL2) during 28 days at enrollment Therapeutic education HBA1c at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Libre 2 | Device | The FSL will be placed on patient for 28 days to measure interstitial glucose |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in glycated hemoglobine at 3 months | biological control of glycated hemoglobin in a laboratory | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change of the time in range, time above range and time below range | data of the freestyle libre | 6 months |
| Rate of change in glycated hemoglobin at 6 months | biological control |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHM Montpellier | Montpellier | 34090 | France |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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We therefore propose a prospective randomised study in 2 arms :
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| Therapeutic education | Other | Therapeutic education |
|
| 6 months |
| Rate of change in weight in kg | In kg each 3,6 months |
| Quality of Life questionnary | EQVOD - Scale of Quality of Life, Obesity and Dietetics | Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months |
| Rate of change arteriel pressure | In mmHg each 3,6 months |
| Concentration of of LDL cholesterol | In g/L each 3,6 months |
| Concentration of Triglyceride | In g/L each 3,6 months |
| Anxiety and depression scale questionnary | HAD - Hospital Anxiety and Depression scale | 14 questions (high score depression, anxiety - low score good health) performed at 3,6 months |
| Quality of Life questionnary | EQ-5D - EuroQoL-5D | From 0 to 100 (100 good quality of life - 0 bad quality of life) performed at 3,6 months |
| Eating behavior questionnaire | DEBQ-Dutch Eating Behaviour Questionnaire | 33 questions (no scale, doctor's assessment of the answers) performed at 3,6 months |
| D004700 | Endocrine System Diseases |